Results-driven Analytical Services Associate Director with extensive experience in the highly regulated pharmaceutical industry. Proven expertise in establishing laboratories compliant with cGMP regulatory standards, ensuring operational excellence and quality assurance. Demonstrated ability to build and lead high-performing teams while maintaining an audit-ready environment that consistently delivers timely and accurate support for API manufacturing. Committed to driving continuous improvement and fostering a culture of compliance and efficiency.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Analytical Services Associate Director
Novo Nordisk
11.2024 - Current
Successfully commissioned the startup of the Novo Nordisk cGMP pharmaceutical testing laboratory to support method Verification, Validations and Transfers
Lead the QC transformation team to implement LIMS, Empower, Instrumentation, and local Standard Operating Procedures
Oversight of computer systems, validation, and compliance (QCIT)
Analytical Services Associate Director
AMPAC Fine Chemicals LLC.
08.2016 - 11.2024
Successfully commissioned the startup of the AFC cGMP pharmaceutical testing laboratory to support manufacturing of APIs.
Microbial Laboratory, Stability chamber qualifications, and retain areas. Authored department and site procedures
Responsible for interviewing, hiring, and managing laboratory employees.
Managed analytical instrument service contracts with multiple vendors necessary to support laboratory start up and continued qualifications/calibrations.
Authored and executed protocols for HPLC’s, GC’s, FTIR’s, Capillary Electrophoresis, UVs, and Stability.
Initiated and developed DEA controlled substances procedures and processes across laboratories.
Primary contact for audits and responsible for acquiring, and maintaining registrations for DEA, Board of Pharmacy, ABC and TTB.
Successfully lead Analytical Technical Transfers between customers and AMPAC QC laboratories.
Lead and supported numerous FDA and customer audits without any critical findings.
Quality Control Senior Manager
UniTao Pharmaceuticals LLC.
01.2015 - 08.2016
Responsible for writing and reviewing laboratory and site wide quality procedures.
Organized laboratory start up activities including setting up an analytical laboratory.
Managed service contracts with multiple vendors necessary to support laboratory start up.
Analytical Services Senior Manager
Boehringer Ingelheim Chemicals, Inc.
02.2004 - 12.2014
Serve as primary intermediate and final testing contact for the value chain and provide direction to members of the IPC, intermediate, and final product testing groups supporting the value chains to perform analytical testing of intermediate or final APIs based upon sound scientific practice and general laboratory and company policies
Experience with Method Development, Method Validation, and technical writing
Provide leadership for the intermediate and final testing group on technical and regulatory matters
Ensure adherence to service level agreements to make certain that final products, Intermediates, special samples, and stability samples are tested, reviewed, and approved within the agreed upon timeframes
Identified innovative technologies, provide innovative ideas, and or solutions to improve business process, test method
Lead a strategic project team to compliantly retire four laboratories due to site closure
Lead the Analytical Services department during FDA, EMA, and DEA regulatory audits with now major or critical findings
QC Supervisor (March 2010 – May 2011)
QC Group Leader (April 2007 – March 2010)
Laboratory Chemist
Analytics Corporation
10.2002 - 02.2004
Supported analytical testing for NIOSH, OSHA, EPA, SW846, and wastewater
Responsible for managing, organizing, and prioritizing assignments among analysts and conveying data back to customers and managers with a quick turnaround time
Responsible for setting up and implementing new instrumentation and standard operating procedures
Chemical Laboratory Technician
Ethyl (Afton) Chemical Corporation
07.1999 - 10.2002
Provided support for the petroleum additives crank case division
Performed small scale organic laboratory synthesis and bench tests
Education
Bachelor of Science - Biology, Minor in Chemistry
Virginia Polytechnic Institute and State University
Blacksburg, VA
05.1999
Skills
GC/ECD/FID/MS
ICP/MS/OES
HPLC
UPLC
Titrimetry
Investigative writing
AA
X-RAY
Auto Titration
21CFR/ICHQ7
UV-VIS
FTIR
TGA
Karl Fischer
Density
Melting Range
Particle Size
Microscopy
Colorimetry
DSC
CGMP’s
FDA
DEA
EP/JP/EP
PH
Refractive index
Method Development
Validation
Stability
CE
ChemStation
Chromeleon
Master Control
Empower
Labware LIMS
Trackwise
Oracle and SA
Lab X
Certification
Green Belt Certification
Leadership Development Program
Inside Out Coaching training
Technical Writing Skills Development training
“Train the Trainer” training, Boehringer Ingelheim Chemicals
Timeline
Analytical Services Associate Director
Novo Nordisk
11.2024 - Current
Analytical Services Associate Director
AMPAC Fine Chemicals LLC.
08.2016 - 11.2024
Quality Control Senior Manager
UniTao Pharmaceuticals LLC.
01.2015 - 08.2016
Analytical Services Senior Manager
Boehringer Ingelheim Chemicals, Inc.
02.2004 - 12.2014
Laboratory Chemist
Analytics Corporation
10.2002 - 02.2004
Chemical Laboratory Technician
Ethyl (Afton) Chemical Corporation
07.1999 - 10.2002
Bachelor of Science - Biology, Minor in Chemistry
Virginia Polytechnic Institute and State University
Senior Clinical Project Manager, Clinical Operations- Phase 3 experience in Rare Disease at Novo Nordisk Inc.Senior Clinical Project Manager, Clinical Operations- Phase 3 experience in Rare Disease at Novo Nordisk Inc.